Events

Trellis 8 Peripheral Infusion System 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Covidien Pty Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2014-RN-01339-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-12-19
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01339-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • 데이터 추가 비고
  • 원인
    Covidien is conducting a recall following two customer complaints of the proximal port being located on distal port location and vice versa. this occurred due to a manufacturing error that has resulted in the distal balloon inflation port incorrectly labelled as proximal and the proximal as distal. covidien have identified a potential for confusion in the trellis 8 inflation port identification. a hazard would arise when one of the balloons is deflated out of sequence prior to aspiration. this may allow lytic and thrombus to escape the treatment area if the incorrectly labelled ports are not identified by the physician during prep or when initially inflating the balloon prior to infusing thrombolytic into the treatment area. this may lead to an extended procedure time and/or bleeding and/or potential thrombus in the systemic circulation and/or emboli where a small piece of dislodged thrombus may travel distally and lead to a possible embolism.
  • 조치
    1. Customers are asked to identify and quarantine affected units; 2. Complete and return the supplied response form regardless if any affected stock is on hand; and 3. Follow the directions in the customer letter to obtain replacement stock should that be required.

Device

Trellis 8 Peripheral Infusion System
  • 모델명 / 제조번호(시리얼번호)
    Trellis 8 Peripheral Infusion SystemModel Number: EVT808015V01Lot Numbers: 9929826, 9930951, 9955126, 9955275 & 9956347Model Number: EVT808025V01Lot Numbers: 9954578 & 9955164Model Number: EVT812015V01Lot Numbers: 9954559 & 9966680Model Number: EVT812025V01Lot Numbers: 9929653, 9953991 & 9954138ARTG Number: 229708
  • 의료기기 분류등급
    Cardiovascular Devices
  • Manufacturer
    Covidien Pty Ltd

Manufacturer

Covidien Pty Ltd
  • 제조사 모회사 (2017)
    Medtronic plc
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DHTGA